Adicet Reports First Quarter 2024 Financial Results and Provides Business Updates
Adicet Bio (Nasdaq: ACET) has reported its Q1 2024 financial results and key business updates. The company is set to initiate a Phase 1 clinical trial for ADI-001 in lupus nephritis in Q2 2024, following FDA clearance. Preliminary data is expected by late 2024 or early 2025. Adicet also presented promising preclinical data on ADI-270 at the ASGCT annual meeting, with plans to file an IND for ADI-270 in renal cell carcinoma in Q2 2024. Financially, the company has a robust balance sheet with $247.6 million in cash and equivalents, projecting fund sufficiency until the second half of 2026. R&D expenses decreased to $23.9 million from $26.8 million YoY, while G&A expenses increased slightly to $7.0 million from $6.6 million YoY. Net loss for Q1 2024 was $28.0 million, or $0.35 per share, an improvement from $30.9 million, or $0.72 per share, in Q1 2023.
- On track to start Phase 1 clinical trial for ADI-001 in lupus nephritis in Q2 2024.
- Presented promising preclinical data for ADI-270, showing robust anti-tumor activity.
- Cash and cash equivalents stand at $247.6 million as of March 31, 2024.
- Projected cash sufficiency until the second half of 2026.
- R&D expenses decreased to $23.9 million compared to $26.8 million in Q1 2023.
- Net loss improved to $28.0 million from $30.9 million YoY.
- Increase in G&A expenses was minimal, up by only $0.4 million YoY.
- Net loss remained high at $28.0 million for Q1 2024.
- G&A expenses increased YoY, indicating higher administrative costs.
- Dependency on regulatory and clinical trial progress for future milestones.
Insights
Adicet Bio’s financial performance for the first quarter of 2024 presents a mixed bag of results, but the company remains in a strong financial position overall. The company reported R&D expenses of
The net loss for the quarter stands at
For investors, the substantial cash reserves and reduction in R&D expenses can be viewed positively, as it demonstrates financial prudence and the ability to sustain long-term operations. However, the continued net losses underscore the inherent risks associated with investing in biotechnology firms, which often require significant capital before achieving profitability.
Adicet Bio is making significant progress with its pipeline of therapies, especially in the domain of autoimmune diseases and cancer. The company is set to initiate a Phase 1 clinical trial evaluating ADI-001 in lupus nephritis in 2Q 2024. Lupus nephritis is a severe inflammation of the kidneys caused by systemic lupus erythematosus, which can lead to kidney failure. The initiation of this trial represents a important milestone as it could potentially address this high unmet medical need.
The promising preclinical data on ADI-270, showcased at the ASGCT Annual Meeting, highlight its robust anti-tumor activity against CD70+ solid and hematological cancers. An IND filing in 2Q 2024 for ADI-270 in renal cell carcinoma marks another strategic step in expanding the company’s oncology portfolio. These developments underscore the versatility and potential of Adicet’s allogeneic gamma delta T cell platform.
For investors, the pipeline’s advancement in both autoimmune diseases and cancer is promising, offering multiple avenues for future growth. The forthcoming clinical trials and data readouts will be pivotal and could drive significant value if positive results are achieved. However, clinical development is fraught with uncertainties and the outcomes of these trials will be critical to the company’s future prospects.
From a market perspective, Adicet Bio is strategically positioned in sectors that exhibit high growth potential. The company’s focus on allogeneic gamma delta T cell therapies sets it apart in the competitive landscape of biotherapeutics. Allogeneic therapies, which are derived from donor cells, offer scalability and off-the-shelf convenience compared to autologous therapies, potentially reducing costs and speeding up treatment timelines.
Moreover, the target indications—autoimmune diseases like lupus nephritis and cancers such as renal cell carcinoma and mantle cell lymphoma—are substantial markets with significant unmet medical needs. The ongoing enrollment of mantle cell lymphoma patients in the Phase 1 GLEAN study of ADI-001, coupled with plans to expand into additional autoimmune indications, reflects a broad and ambitious clinical development strategy.
For investors, the company’s diversified pipeline provides multiple shots on goal, reducing reliance on a single product or indication. The upcoming clinical updates and IND filings will be key catalysts to watch. However, it’s essential to keep an eye on the competitive landscape and regulatory environment, which can impact market dynamics and the company’s strategic positioning.
On track to initiate Phase 1 clinical trial evaluating ADI-001 in lupus nephritis in 2Q 2024
Presented promising preclinical data on ADI-270 at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting; on track to file investigational new drug (IND) in renal cell carcinoma in 2Q 2024
Strong balance sheet with
“We are poised for a transformational year in 2024 as we advance our gamma delta T cell platform in autoimmune diseases and prepare to initiate a Phase 1 study evaluating our lead candidate ADI-001 in lupus nephritis in the second quarter of this year,” said Chen Schor, President and Chief Executive Officer at Adicet Bio. “We recently shared encouraging preclinical data on ADI-270 at the ASGCT annual meeting highlighting its highly differentiated profile and illustrating ADI-270’s robust anti-tumor activity in multiple CD70+ solid and hematological cancer indications and supporting ADI-270’s clinical development. In parallel, we are continuing to enroll mantle cell lymphoma patients in our ongoing Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma and expect to share a clinical update in the second half of this year.”
First Quarter 2024 and Recent Operational Highlights:
Autoimmune diseases
- On track to initiate Phase 1 study of ADI-001 in lupus nephritis in 2Q 2024. In December 2023, the FDA granted clearance for Adicet's IND application to evaluate ADI-001 in lupus nephritis. The Company plans to commence a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis in the second quarter of 2024. Preliminary data from the study are anticipated during the fourth quarter of 2024 or first quarter of 2025, depending on patient enrollment and study site activation.
- Continuing to expand ADI-001 into additional autoimmune diseases. Adicet plans to continue broadening the clinical applications of ADI-001 to include additional autoimmune indications. The Company expects to share preliminary clinical data in the fourth quarter of 2024 or first half of 2025, subject to regulatory clearances and contingent upon successful site initiation and patient enrollment in the relevant clinical protocols.
Hematologic malignancies and solid tumor indications
- Presentation of preclinical data from ADI-270 at the ASGCT Annual Meeting. In May 2024, Adicet presented promising preclinical data in an oral presentation at the ASGCT annual meeting demonstrating robust anti-tumor activity of ADI-270, an armored allogeneic “off-the-shelf” gamma delta CAR T cell therapy candidate targeting CD70+ cancers, in multiple CD70+ solid and hematological tumor indications. Based on ADI-270’s promising profile in preclinical studies to date, Adicet expects to submit an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024. Following regulatory clearance and contingent upon study initiation progress, the Company intends to present clinical data from a Phase 1 study in the first half of 2025.
- Enrollment of mantle cell lymphoma (MCL) patients in ongoing ADI-001 Phase 1 GLEAN study. Adicet is continuing to enroll MCL patients in the Phase 1 trial evaluating ADI-001 in relapsed or refractory non-Hodgkin’s Lymphoma (NHL). The Company remains on track to provide a clinical update on safety, efficacy and 6-month complete response data in MCL patients in the second half of 2024.
Financial Results for First Quarter 2024:
-
Research and Development (R&D) Expenses: R&D expenses were
$23.9 million $26.8 million $3.1 million -
General and Administrative (G&A) Expenses: G&A expenses were
$7.0 million $6.6 million $0.4 million $0.2 million $0.1 million -
Net Loss: Net loss for the three months ended March 31, 2024 was
$28.0 million $0.35 $5.7 million $30.9 million $0.72 $4.8 million -
Cash Position: Cash and cash equivalents were
$247.6 million $231.6 million
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
Forward-Looking Statements
This press release contains "forward-looking statements" of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: preclinical and clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 and ADI-270, including the potential submission or timing of clearance of INDs, and the potential safety, durability, tolerability and efficacy of these product candidates as well as their potential promising profiles; the progress, timing and success of the Company’s ongoing and planned Phase 1 clinical trials of ADI-001 in autoimmune diseases and cancer, including expectations for site activation, enrollment and data readouts; the Company’s plan to expand into other autoimmune indications in the future; the Company’s expectations regarding regulatory filings and clearances, including the submission of an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024; and expectations regarding the Company’s uses of capital, expenses and financial results, including the expected cash runway.
Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Adicet’s most recent annual report on Form 10-K and our periodic reports on Form 10-Q and Form 8-K filed with the
ADICET BIO, INC. Consolidated Statements of Operations (in thousands, except share and per share amounts) (Unaudited) |
||||||||
|
|
Three Months Ended March 31, |
||||||
|
|
2024 |
|
2023 |
||||
Operating expenses: |
|
|
|
|
||||
Research and development |
|
|
23,897 |
|
|
|
26,756 |
|
General and administrative |
|
|
6,974 |
|
|
|
6,566 |
|
Total operating expenses |
|
|
30,871 |
|
|
|
33,322 |
|
Loss from operations |
|
|
(30,871 |
) |
|
|
(33,322 |
) |
Interest income |
|
|
2,918 |
|
|
|
2,666 |
|
Interest expense |
|
|
(2 |
) |
|
|
(19 |
) |
Other expense, net |
|
|
(61 |
) |
|
|
(206 |
) |
Loss before income tax provision |
|
|
(28,016 |
) |
|
|
(30,881 |
) |
Income tax provision |
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(28,016 |
) |
|
$ |
(30,881 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.35 |
) |
|
$ |
(0.72 |
) |
Weighted-average common shares used in computing net loss per share, basic and diluted |
|
|
79,071,652 |
|
|
|
42,955,688 |
|
ADICET BIO, INC. Consolidated Balance Sheets (in thousands) (Unaudited) |
||||||||
|
|
March 31, |
December 31, |
|||||
|
|
2024 |
|
2023 |
||||
Cash and cash equivalents |
|
$ |
247,589 |
|
|
$ |
159,711 |
|
Working capital |
|
|
232,889 |
|
|
|
142,985 |
|
Total assets |
|
|
293,095 |
|
|
|
207,295 |
|
Accumulated deficit |
|
|
(408,788 |
) |
|
|
(380,772 |
) |
Total stockholders’ equity |
|
|
258,804 |
|
|
|
170,175 |
|
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Adicet Bio, Inc.
Investor and Media Contacts
Anne Bowdidge
abowdidge@adicetbio.com
Janhavi Mohite
Stern Investor Relations, Inc.
212-362-1200
janhavi.mohite@sternir.com
Source: Adicet Bio, Inc.
FAQ
When will Adicet Bio begin the Phase 1 clinical trial for ADI-001 in lupus nephritis?
What were Adicet Bio's cash and cash equivalents as of March 31, 2024?
How much did Adicet Bio's R&D expenses decrease in Q1 2024 compared to Q1 2023?
What is the expected timeline for preliminary data on the ADI-001 lupus nephritis study?
What was Adicet Bio's net loss in Q1 2024?
What financial projection does Adicet Bio have for its cash reserves?
